MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for END EXPIRATORY FILTER RT020 manufactured by Fisher & Paykel Healthcare Ltd.
[137842717]
(b)(4). We are currently in the process of retrieving further information. We will provide a follow up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
[137842718]
A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that an rt020 end expiratory filter became blocked after approximately 4-6h of use on a patient. As a result, they were not able to obtain inspiratory tidal volume (vti) from the ventilator. After changing the filter the issue was resolved. There was no medical intervention required. There was no patient consequence reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2019-00133 |
| MDR Report Key | 8360713 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-01-24 |
| Date of Event | 2019-01-23 |
| Date Mfgr Received | 2019-05-09 |
| Date Added to Maude | 2019-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. FARANAK GOMAROONI |
| Manufacturer Street | 173 TECHNOLOGY DRIVE SUITE 100 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494534000 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
| Manufacturer City | AUCKLAND, 2013 |
| Manufacturer Country | NZ |
| Manufacturer Postal Code | 2013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | END EXPIRATORY FILTER |
| Generic Name | CAH |
| Product Code | CAH |
| Date Received | 2019-02-21 |
| Model Number | RT020 |
| Catalog Number | RT020 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-21 |